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USA Today investigates how neuroleptic psychiatric drugs (also called "antipsychotics") that are usually given to adults, can have special hazards when given to children, as they are in increasing numbers.

Adult antipsychotics can worsen troubles

Date Published:

May 02, 2007 03:00 AM

Author:
Marilyn Elias

Source:
USA Today

For original article with grid of some of the neuroleptics, plus side bars, click here.

Evan
Kitchens, a cheerful fourth-grader who loves basketball and idolizes
his 16-year-old brother, had been hospitalized for mental illness by
the time he was 8.

The boy from Bandera,
Texas, was aggressive and hyperactive and had been diagnosed with a
variety of other ailments, including obsessive-compulsive disorder and
an autism spectrum disorder.

A couple of
years ago, Evan was taking five psychiatric drugs, says his mother,
Mary Kitchens. Two were so-called atypical antipsychotics, a group of
relatively new drugs approved by the Food and Drug Administration for
treating adults with schizophrenia or bipolar disorder.

"Evan
was a walking zombie on all those drugs," Kitchens says. At the
harrowing nadir two years ago, she wondered whether her son would
survive, let alone live a normal life.

Evan
shook with severe body tremors and hardly talked. He had crossed eyes,
a dangerously low white blood cell count and a thyroid disorder, all
symptoms that emerged after he started the atypical antipsychotic
drugs, Kitchens says. Now, he has been weaned from the drugs and takes
medicine only for attention-deficit disorder, she says. And he is
mentally healthier than he has ever been.

These
six new antipsychotic drugs — Clozaril, Risperdal, Zyprexa, Seroquel,
Abilify and Geodon — are not approved for children, but doctors can
prescribe them to kids "off label." And prescribing atypical
anti-psychotics for aggressive children such as Evan is leading the
field in a growing pediatric business, according to a new analysis of a
federal survey by Vanderbilt Medical School researchers.

Outpatient
prescriptions for children ages 2 to 18 jumped about fivefold — from
just under half a million to about 2.5 million — from 1995 to 2002, the
survey shows.

At the same time, reports of
deaths and dangerous side effects potentially linked to the drugs are
increasing. A USA TODAY analysis of Food and Drug Administration data
shows at least 45 deaths of children from 2000 to 2004 where an
atypical was considered the "primary suspect." More than 1,300 cases
reported bad side effects, including some that can be life threatening,
such as convulsions and a low white blood cell count.

Non-drug treatments

Treating children's disruptive behavior with pills is a complicated issue and the subject of debate among experts.

"In
my experience, and that of many psychiatrists, antipsychotics are often
overused for aggression in young patients," says Ronald Pies, a
clinical professor at Tufts University and author of Handbook of Essential Psychopharmacology.

That doesn't mean it's necessarily wrong to give the pills, he adds.

Nobody
disputes that the lives of schizophrenic or severely manic children
might be saved by antipsychotics. But many non-drug treatments can help
to keep aggressive, disruptive children off the atypicals, says John
March, chief of child and adolescent psychiatry at Duke University
School of Medicine.

So much hinges on whether safer treatments can work for a child.

Kids
who show up on antipsychotics for aggression often can be weaned off if
there are family changes, says behavioral pediatrician Lawrence Diller
of Walnut Creek, Calif. For instance, adolescents may lash out angrily
if their parents are fighting or discipline is inconsistent, Diller
says. In a divorce, the child sometimes ends up with the less effective
parent.

Last year, Diller saw an 8-year-old
boy on four psychiatric drugs, including an atypical. He lived with his
mother, "a highly anxious, incompetent parent." When he went to live
with his father, his symptoms virtually disappeared, and he didn't need
any drugs, Diller says.

Child psychiatrist
George Stewart says he has seen dozens of aggressive children weaned
off the atypical antipsychotic drugs in his consulting work and as
medical director of a residential treatment facility in Concord, Calif.
Too often, he says, doctors give the drugs without considering family
conditions or life experiences that cause aggressive behavior, which
can be changed with intensive counseling. Three examples he offers:

•
A boy younger than 3 was treated with two antipsychotics at a
therapeutic preschool for kids with severe behavior problems. Stewart
got a full family history, discovering his teen mother had a series of
abusive boyfriends. "He was acting out due to that, but nobody took the
time to find out what was going on at home," says Stewart, who worked
with the mom to improve conditions. "She settled down."

The child was taken off atypicals and is doing fine.

•
A 12-year-old boy with out-of-control rage — "we're talking smearing
poop all over the 'quiet room' " — was treated at Stewart's center.
Intensive therapy identified the sources of his rage and taught the boy
how to cope. He returned home, off all meds.

•
A teen girl seemed to be intractably violent. "She was trying to stab
pencils in people's eyes," Stewart says. It turned out she had been
raped and experienced other severe trauma. She was weaned off
antipsychotics and counseled. Now in her late teens, she's living
independently and doing well with no psychiatric drugs.

One
of the most disturbing, potentially dangerous trends linked to
atypicals is called "polypharmacy": routinely giving kids several
psychiatric drugs, says child psychiatrist Joseph Penn of Bradley
Hospital and Brown University School of Medicine in Providence. "We
know very little about the interaction of these drugs, the effects they
could be having on kids," he says.

The
benefits of prescribing multiple drugs may outweigh risks in some
cases, but Penn says he is appalled at how many times he has seen the
mega-powerful atypicals prescribed to children suffering from insomnia
when they're taking other medicines.

"I've
seen hundreds of cases," he says, "and often parents don't seem to have
been told about the many less risky prescription and non-prescription
options out there."

Sometimes medical
conditions or drugs for attention-deficit hyperactivity disorder cause
the insomnia. Rather than attacking causes, doctors add an atypical to
the mix, he says.

More research needed

There
has been little carefully controlled, long-term research on children
taking most psychiatric drugs, including the atypical antipsychotics.
The FDA is trying to get more pediatric research on the atypicals, says
Thomas Laughren, the agency's director of the psychiatry products
division.

The FDA has asked five
pharmaceutical companies that make the drugs to test them in children
with schizophrenia and bipolar disorder, the uses they're approved for
in adults. Under law, they can get a six-month extension on their
patents for doing these studies.

Also, the
drug companies are doing their own pediatric studies on children with
disorders as diverse as ADHD, autism, conduct disorder and Tourette's
syndrome.

Janssen LP has applied to the FDA
for approval to use its atypical antipsychotic, Risperdal, in the
treatment of symptoms of autism, says Ramy Mahmoud, vice president of
medical affairs for Janssen.

The National
Institute of Mental Health also is conducting pediatric studies, but
the research is primarily funded and supervised by pharmaceutical
companies.

Even if the companies win
approval, it won't guarantee safety or effectiveness of the drugs in
children, says David Graham of the FDA Office of Drug Safety, who
emphasizes he doesn't speak for the agency. "You basically know the
drug isn't cyanide. You don't know much else," says Graham, who was the
whistle-blower in the 2004 Vioxx heart disease scandal. Industry-funded
trials are four to five times more likely than independent studies to
show effectiveness for a drug, he says.

According
to a research review published in February, 90% of drug-company-funded
studies come up with findings that support the company's drug.

In
head-to-head research testing more than one atypical antipsychotic
drug, the outcomes are contradictory, coming down on the side of
whichever company is paying for the research. (The research included
studies of Risperdal, Zyprexa, Clozaril and Geodon, but none on
Seroquel or Abilify.)

"It appears that
whichever company sponsors the trial produces the better antipsychotic
drug," writes lead author Stephan Heres of the Technical University of
Munich in the American Journal of Psychiatry.

And the short-term, smaller studies required of companies rarely detect any but the most glaring problems, Graham says.

"The
American public is operating under the illusion that a drug is safe
just because it's approved by the FDA," says Jeffrey Lieberman,
chairman of psychiatry at the Columbia College of Physicians and
Surgeons in New York. Studies lasting a few weeks to a few months, with
a couple of thousand patients total, won't reveal all that's wrong with
a drug, he says.

Laughren agrees that "it's
very difficult to answer every question we'd like to answer with these
studies, because obviously they're not huge. Sometimes bad things that
happen are going to be discovered only when a drug is used more widely."

He
says he, too, shares concern about the antipsychotics prescribed for
children without proof of safety or effectiveness. Much more pediatric
information on the atypicals will be available within five years, he
says.

Recommended changes

Others
favor fundamental changes to get the needed facts about drug safety.
Lieberman thinks one solution would be for the FDA to be given a new
legal authority: the right to require drug companies seeking to gain
approval of a drug to contribute to a collective pool at the National
Institutes of Health. The NIH could supervise larger safety and
effectiveness studies of medicines after they're on the market.

A
national electronic medical records database that would capture all bad
side effects of drugs, and require ages and diagnoses, could do a lot
to protect children from careless prescribing and reveal the effects of
antipsychotics, Duke's March says.

"We know so little about what's happening to all the kids who are getting these powerful antipsychotics," he says.

March
also thinks more private insurers ought to insist that aggressive
children with short fuses try non-drug therapies proven to help before
doctors jump in with antipsychotics. These pills can seem like an
appealing "quick fix," he says, so they're popular.

For
foster children with mental health problems, medication is a mainstay,
says Ira Burnim, legal director at the Bazelon Center for Mental Health
Law, an advocacy group for those with mental disabilities. There's
proof that the most effective care is "wraparound," he says, meaning
that caseworkers touch base regularly with a child's school, doctor,
foster and perhaps birth families, in addition to ensuring therapy or
medication as needed.

"Now they're medicating
many kids instead of giving them the services they need. But there's
very little time spent with psychiatrists and not much attention paid
to side effects from these heavy drugs," Burnim says.

States
vary in how much wraparound care they provide for foster kids, "but a
typical pattern is patches here and there," Burnim says. "They rely
heavily on medications like the antipsychotics. This costs more than
wraparound in the long run, and it's less safe for the kids."

March
considers the widespread use of antipsychotics on children without
proof of safety or effectiveness "a very large experiment." Many kids
are getting the short end of the stick, he says. "We're not even
gathering good data on the outcome of the experiment. It's the worst of
all possible worlds."

We are MFI

Cindi Fisher, mother of psychiatric survivor

Cindi Fisher has fought for years for her son, who has experienced forced psychiatric drugging and other human rights violations in the State of Washington. She has even held protest fasts on her son's behalf (see photo of Day One). Cindi says: "In the past, advocating for my 33-year-old psychiatric survivor son over the years has been very frustrating and has sometimes felt hopeless! Now, as a member of MindFreedom, I feel I have the voice of thousands to join me. My effectiveness and awareness as an advocate has indeed multiplied a thousand times. Thank you David and MindFreedom for your many years of work to build such a powerful and empowering organization!"